Anesthesia, Local, Breast Cancer
Conditions
Keywords
PECS, ESP, RCT
Brief summary
Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period. PECS II block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery. ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this technique in breast surgery to provide analgesia but to date no studies comparing these technique exists. Our hypotesis is that this two technique are equally able to provide analgesia in breast surgery. Study type: RCT, single blind.
Interventions
PROCEDUREESP BLOCK
local anesthetic will be injected between transverous process and erector spinae muscle
PROCEDUREPECS BLOCK
local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml)
Sponsors
University of Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
ESP block and PECS block will be executed by an anesthesiologist that will not follow the patient during the surgery. Anesthesiologist responsible for the surgery will be not aware of the block executed on the patient Anesthesiologist and surgeon responsible for postoperative therapy will be not aware of the block executed on the patient
Intervention model description
This is a single-centre, prospective; double blinded randomised interventional clinical trial. Patients will be randomly allocated to group PECS or ESP using a closed envelope technique. Group PECS will receive PECS II block as described by Blanco using 30 ml Levobupivacaine 0.25% Group ESP will receive ESP block as described by forero using 30 ml Levobupivacaine 0.25% at T5 level. Blocks will be executed after general anesthesia induction. All partecipants will receive Fentanyl 2 mcg/kg and Propofol 2 mg/kg for induction. Anesthesia will be mantained with Propofol to obtain a BIS level between 40-50. Patients will receive Fentanyl 33 mcg whenever blood pressure and/or hear rate raise more than 20% from baseline after surgical stimulation. At the end of the surgery patients will receive acetominophen 1 g. postoperative therapy: acetominophen 1g/8hr and ketoprofen 100 mg/12hr. Patients will receive 2 mg Morphine whenever a NRS \> 3.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Mastectomy program with axillary clearence
Exclusion criteria
* bilateral surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Fentanyl consumption | Intraoperative | Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS at 12 hour | twelth postoperative hour | NRS (0-10) difference at twelth postoperative hour between ESP group and PECS group |
| NRS at 24 hour | twentyfourth postoperative hour | NRS (0-10) difference at twentyfourth postoperative hour between ESP group and PECS group |
| Patient satisfaction at 24 hour | postoperative period (24h) | Patient satisfaction (0-10) difference regarding anesthesia management at twentyfourth postoperative hour between ESP group and PECS group |
| Time to first opioid consumption in the postoperative period | postoperative period (24h) | Time (minutes) to first opioid consumption in the postoperative period |
| NRS at 6 hour | sixth postoperative hour | NRS (0-10) difference at sixth postoperative hour between ESP group and PECS group |
| Nausea and vomit incidence | postoperative period (24h) | Incidence of nausea and vomiting in postoperative period |
| Other complication incidence | postoperative period (24h) | Incidence of other complcations linked to anesthesia in postoperative period |
| Intraoperative Fentanyl consumption(mcg/kg/h) | Intraoperative | Intraoperative fentanyl dose (mcg/kg/h) difference between ESP group and PECS group. |
| Postoperative morphine consumption | postoperative period (24h) | postoperative morphine dose (mg) difference between ESP group and PECS group. |
Countries
Italy
Outcome results
None listed